FDA decisions and clinical data: the main drivers in small-cap biotech through the end of June

Since the beginning of 2025, the SPDR S&P Biotech ETF (ticker: XBI), one of the main benchmarks for the biotechnology industry, is up 35.9%. The fund tracks the S&P Biotechnology Select Industry Index and, thanks to its more even asset allocation, reflects the performance of small- and mid-cap companies well.

For the biotechnology sector, the growth of quotations is largely determined not by market-wide factors, but by specific corporate events. In the coming weeks, the market will be watching for regulatory decisions and the publication of clinical trial results - these events often become the main driver of growth or decline in biotech companies' shares.

The Bloomberg Intelligence catalyst calendar for June (available in Oninvest editorial office) is full of FDA decisions and results of clinical trials. Among the nearest events in the SMID-cap segment investors should pay attention to the companies:

- Spero Therapeutics (June 18),

- Achieve Life Sciences (June 20),

- Viridian Therapeutics (June 30),

- MBX Biosciences (June 12-13),

- Intellia Therapeutics (June 13).

These five ideas are united by betting not on current profits, but on the probability of a specific event. This approach is suitable for investors who are prepared for high volatility and who take into account the specifics of the sector: in small-caps biotech, quotes often move in spurts influenced by news and clinical results.

Achieve Life Sciences is developing cytisinicline, a drug for smoking cessation and, potentially, e-cigarettes. The company had no revenue in the first quarter of 2026, but cut operating expenses to $10.5 million from $12.9 million a year earlier and its net loss to $10.2 million from $12.8 million. In April, the company reported a private placement of up to $354 million (it had $29.3 million on its balance sheet before that), providing funding for the ORCA-V2 study, preparing for commercial launch and moving production to the US.

If cytisiniclin receives approval, it could become the first new smoking cessation therapy approved by the FDA in more than 20 years. Notably, the company is awaiting a rejection letter from the FDA pending resolution of comments related to the former manufacturing contractor, not the drug itself, after which it plans to reapply in the fourth quarter of 2026.

In May 2026, Jones Trading gave Achieve Life Sciences a Buy rating with a $20 target price - about 250% above their current value. The company's stock now has eight ratings from Wall Street analysts and all of them are Buy, according to MarketWatch. The average target is $13.1, which implies the stock more than doubles in value.

The company is developing drugs to treat thyroid ophthalmopathy, a disease in which inflammation of tissues around the eyes markedly reduces the quality of life. In the first quarter of 2026, the company generated to ken revenue of $140,000, recorded a net loss of $104.9 million versus $86.9 million a year earlier and had $762.2 million in cash and short-term investments.

The main catalyst for the stock is the FDA's decision on veligrotug, which is expected on June 30, 2026. If approved, it could become the company's first commercial product. In parallel, Viridian is developing elegrobart, a subcutaneous version of the therapy in a self-injection format. In May, the company presented data from the REVEAL-2 study, where the drug showed a proptosis response in 50-54% of patients versus 15% in the placebo group.

RBC Capital Markets raised their target price on the company's stock to $34 on May 5 and maintained an Outperform rating (buy recommendation). 16 Wall Street analysts have rated them Buy, one has assigned a Hold rating. The average target price is $33.9, about double the closing price on June 10.

An early-stage biotechnology company working in the field of endocrine and metabolic diseases. Investors are most interested in two programs: canvuparatide for the treatment of chronic hypoparathyroidism and MBX 4291 for the treatment of obesity.

The company had $440 million in cash and investments in the first quarter of 2026, which management estimates should be enough to fund operations through 2029. Research expenses fell to $18.5 million from $22.41 million a year earlier, while the net loss was virtually unchanged at $23.6 million.

The closest catalyst is canvuparatide, a weekly parathyroid hormone analog. The company plans to present Phase 2 study results and one-year follow-up data at the ENDO 2026 conference on June 12, with Phase 3 launch expected in the third quarter of 2026.

In May 2026, the company reported initial data for MBX 4291 for the treatment of obesity, targeting the GLP-1 and GIP hormone pathways. However, the company plans to disclose more important 12-week data in the fourth quarter of 2026. Citizens JMP raised its target price to $86 and Barclays raised its target price to $70, suggesting a potential upside from the current value of 177.5% and 125%, respectively. 11 analysts advise buying MBX Biosciences shares and only one advises selling. The average target is $69.

A key driver for the company is the FDA's decision on tebipenem HBr on June 18, 2026, as the current valuation of the business is largely based on the likelihood of its market entry. Tebipenem HBr is an oral antibiotic of the carbapenem class that has the potential to replace a portion of intravenous regimens for the treatment of complicated urinary tract infections. In December 2025, the company's partner, GSK, resubmitted an application to register the drug for the treatment of complicated urinary tract infections, including pyelonephritis.

The application is based on the results of the PIVOT-PO study in which tebipenem HBr was compared to the intravenous antibiotic imipenem-cilastatin. The study was prematurely terminated in May 2025 after an interim analysis showing the efficacy of the drug.

According to Marketwatch, the company now has only one rating, Hold, with a target price of $4. It suggests the stock is up 57.5% from its closing price on June 10.

The company develops drugs based on CRISPR gene editing technology. The company's most advanced program is lonvo-z (lonvoguran ziclumeran), a single gene therapy to prevent attacks of hereditary angioedema.

In the first quarter of 2026, Intellia reported positive results from the HAELO study: the drug reduced seizure frequency by 87% compared to placebo, and 62% of patients were seizure-free and did not require additional therapy. Intellia has already started a staged filing for registration and expects to complete it in the second half of 2026, with a potential launch of the drug in the US expected in the first half of 2027.

The closest catalyst will be the data that Intellia will present on June 13 at the EAACI Congress. Although we are not talking about a regulatory decision, this is an important event for the investment case: the market will get more detailed information about the efficacy and safety of one of the most advanced programs in the field of CRISPR therapeutics.

Analysts' estimates diverge noticeably: Jones Trading recommends the stock to buy with a target price of $29, while J.P. Morgan maintains an Underweight rating and target price of $8. In total, the company's stock has 11 "buy," eight "hold" and two "sell" ratings, MarketWatch shows. The average rating is $26.6 and implies a potential upside of more than double the current value.

Does not constitute individualized investment advice.